Study of ARC1779 Injection in Patients with Thrombotic Microangiopathy

• Research type

  Research Study

• Full title

  A Randomized, Double-blind, Placebo-controlled, Clinical Outcome Study of ARC1779 Injection in Patients with Thrombotic Microangiopathy.

• IRAS ID

  6602

• Sponsor organisation

  Archemix Corp

• Eudract number

  2008-001872-54

• ISRCTN Number

  N/A

• Research summary

  The purpose of this study is to investigate the effectiveness and safety of ARC1779 Injection in patients with thrombotic microangiopathy (TMA) disorders, these are patients, who have had blood clots in the arterioles and capillaries (types of blood vessels) which in turn causes tissue injury to organs including the brain, heart and kidneys. The main cause of TMA is a large ammount of the glycoprotein Von Willebrand Factor (VWF) which is present in the blood. This study will investigate whether the study drug ARC1779 inhibits the blood clotting function of VWF by stopping its interaction.Presently, there are no commercially available drugs specifically approved for use in this disease process.The study will be a treatment study by the sponsor Archemix Corp and will recruit from a single site in the United Kingdom, the University College London Hospitals. Other countries which are involved in this study inculde Austria, Canada, Italy, Switzerland and the United States. In-patients will be enrolled with a 1st or 2nd episode of TMA. Assessments include the taking of blood, assessment of neurocognitive function by a test on a computer called CogState battery, a Quality of Life Questionnaire to assess the patients health and well being and cardiac and cranial magnetic resonance imaging (MRI) which uses powerful magnets and radio waves to construct clear detailed pictures of the heart and brain.

• REC name

  London - Queen Square Research Ethics Committee

• REC reference

  08/H0716/96

• Date of REC Opinion

  29 Jan 2009

• REC opinion

  Further Information Favourable Opinion